[26G-pm] Regulatory sciences (pharmaceuticals, etc.)-1

Sat. Mar 26, 2022 1:30 PM - 2:42 PM [Room G] Exhibition Room 212 (Bldg. 2: 1F)

Chair: Rumiko Hosoki

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1:30 PM - 1:42 PM

[26G-pm01S] Regulatory science for an innovative medical material: safety evaluation of Matching Transformation System (MA-T)

○Takahiro Noguchi¹, Keisuke Tachibana², Tsuyoshi Inoue², Masuo Kondoh² (1. Sch. Pharm. Sci., Osaka Univ., 2. Grad. Sch. Pharm. Sci., Osaka Univ.)

1:42 PM - 1:54 PM

[26G-pm02S] Regulatory science for innovative drug delivery systems: safety and efficacy evaluation of paracellular permeation enhancers

○Sayaka Sugimura¹, Keisuke Tachibana², Masuo Kondoh² (1. Sch. Pharm. Sci., Osaka Univ., 2. Grad. Sch. Pharm. Sci., Osaka Univ.)

1:54 PM - 2:06 PM

[26G-pm03S] Regulatory Science for innovative drug delivery system to the brain: Safety and efficacy evaluation of a claudin-5 modulator in a non-human primate model

○Itsuki Nishino¹, Keisuke Tachibana², Yosuke Hashimoto², Yumi Iwashita², Keisuke Shirakura², Yoshiaki Okada², Hiroyuki Takeda³, Hiroki Kuniyasu⁴, Masuo Kondoh² (1. Sch. Pharm. Sci., Osaka Univ., 2. Grad. Sch. Pharm. Sci., Osaka Univ., 3. PROS, Ehime. Univ., 4. Grad. Sch. Medic. Sci. Nara Medical Univ.,)

2:06 PM - 2:18 PM

[26G-pm04S] Differences in vaccination against infectious diseases approval judgment for pregnant women by regulatory agencies in each country researched from the package insert, etc.

○Yuusuke Oohashi¹, Yumiko Nomura¹, Atsuko Okumoto¹, Kiyohito Noda², Shin Okuda², Junhyun Kim², Mayumi Shikano^1,2 (1. Grad. Sch. Pharm. Sci., Tokyo Univ of Science, 2. Pharm. Sci., Tokyo Univ of Science)

2:18 PM - 2:30 PM

[26G-pm05S] Investigation of the status of Japan’s participation in multi-regional clinical trials and the related factors

○Daisuke Komuta¹, Mamoru Narukawa¹ (1. School of Pharmacy, Kitasato Univ.)

2:30 PM - 2:42 PM

[26G-pm06S] Study of Adult and Pediatric Simultaneous approval in Japan and the United States

○Hirohito Mori¹, Miho Yamamoto^1,2, Naoki Matsumaru¹, Katsura Tsukamoto¹ (1. Gifu Pharm. Univ., 2. Otsuka Pharm.)

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